FDA 510(k)

FEops HEARTguide Simulation Application

K-Number: K250635 · 2025-11-25

Decision Date2025-11-25

Product CodeQQI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FEops HEARTguide Simulation Application is the device name listed in this FDA 510(k) record. The listed applicant is Feops NV. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K250635. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEops HEARTguide Simulation Application?

FEops HEARTguide Simulation Application is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Feops NV. The 510(k) number is K250635.

When did FEops HEARTguide Simulation Application receive FDA 510(k) clearance?

FEops HEARTguide Simulation Application received FDA 510(k) clearance on 2025-11-25, under 510(k) number K250635.

Who is the listed applicant for FEops HEARTguide Simulation Application?

The FDA 510(k) record lists Feops NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEops HEARTguide Simulation Application?

The FDA product code for FEops HEARTguide Simulation Application is QQI.

Other records listing Feops NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACA K214066FEops HEARTguide

Related Devices (Code: QQI)

K223809PrecisionTAVI (v1.1)Dasi Simulations K214066FEops HEARTguideFeops NV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.